Clinical Outcome After Lumbar Fusion

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Procedure: Lumbar Fusion

• Registration Number: NCT03155789
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

Brief Summary

The main objective of this prospective study is to compare the clinical outcomes after lumbar fusion for chronic low back pain using the four techniques commonly employed in our surgical practice. Lumbar fusion stops motion at a painful vertebral segment, which can decrease back pain. The four techniques are standard transforaminal lumbar interbody fusion (S TLIF), minimally invasive transforaminal lumbar interbody fusion (MI TLIF), extreme lateral interbody fusion (XLIF), and axial lumbar interbody fusion (AxiaLIF). Each differ in where incisions are made and level of invasiveness; not all may be implemented in each surgical case. The four different techniques are all standard approaches with different advantages and have yet to be compared in efficacy for relieving chronic low back pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-05
• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Study First Posted: 2017-05-16
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Severe chronic low back pain (at least 7 out of 10 on the VAS scale).

  • Age: 25-65 years.
  • Pain duration at least 2 years.
  • The treating surgeon should interpret the pain as emanating from L4-S1.
  • The patient must have had unsuccessful maximal possible conservative (non surgical) treatment for at least one year.
  • Radiographic evidence (MRI, CT, CT-SPECT, and/or plain films) of degenerative changes ("spondylosis")

Exclusion Criteria

• Psychiatric illness or evidence of emotional instability.

  • Previous spine surgery except for successful removal of a herniated disc more than 2 years before entering the study and with no persistent nerve root symptoms.
  • Specific radiologic findings, such as fractures, infection, inflammatory process, or neoplasm.
  • Obvious painful and disabling arthritic hip joints and anamnestic and radiologic signs of spinal stenosis.
  • Involvement in Workman's Comp or litigation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low Back Pain emanating from L4-5 and L5-S1	Lumbar Fusion	1. S TLIF at L4-5 and L5-S1 (n=10) 2. MI TLIF at L4-5 and L5-S1 (n=10) 3. XLIF at L4-5 and L5-S1 (n=10)
Low Back Pain emanating from L4-5	Lumbar Fusion	1. S TLIF at L4-5 (n=10) 2. MI TLIF at L4-5 (n=10) 3. XLIF at L4-5 (n=10)
Low Back Pain emanating from L5-S1	Lumbar Fusion	1. S TLIF at L5-S1 (n=10) 2. MI TLIF at L5-S1 (n=10) 3. XLIF at L5-S1 (n=10)

Primary Outcome Measures

Name	Time	Method
Change from Baseline Visual Analog Scale (VAS)	2 weeks, 6 months, 1 year	This is part of the Patient Questionnaire primary outcome measure. A Visual Analogue Scale (VAS) is a measurement instrument that measures the intensity or frequency of pain across a continuum of values.
Change from Baseline Prolo Functional and Economic Score	2 weeks, 6 months, 1 year	This is part of the Patient Questionnaire primary outcome measure. The Prolo Score is a 10-point scale consisting of only two questions evaluating the functional and economic status of the patient.
Change from Baseline Dallas Pain Questionnaire (DPQ)	2 weeks, 6 months, 1 year	This is part of the Patient Questionnaire primary outcome measure. The Dallas Pain Questionnaire (DPQ) assess the amount of chronic spine pain that affects the patient's daily and work-leisure activities, anxiety-depression, and social interest.
Change from Baseline Short Form 12 (SF-12)	2 weeks, 6 months, 1 year	This is part of the Patient Questionnaire primary outcome measure. The Short Form 12 (SF-12) was designed to measure the patient's functional health and well-being.
Change from Baseline Oswestry Disability Index (ODI)	2 weeks, 6 months, 1 year	This is part of the Patient Questionnaire primary outcome measure. The Oswestry Disability Index measures a patient's impairment and quality of life due to pain.

Secondary Outcome Measures

Name	Time	Method
Radiologic Fusion Rates	6 months and 1 year	Fusion rates will be evaluated by flexion-extension X-rays and CT imaging.